ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment (CROCODILE)

Observational study to assess barriers for colorectal cancer treatment compliance in India, including quantitative assessment of catastrophic expenditure incidence and qualitative assessment of financial and non-financial barriers.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Health Care Utilization; Treatment Compliance

Detailed Description

Objective: To identify a vulnerable group of colorectal cancer patients in India who cannot afford or are unable to comply with a treatment plan for colorectal cancer.

Aims:

1. To identify the proportion of CRC patients suffering catastrophic expenditure due to out-of-pocket payments for cancer treatment.
2. To determine the proportion of patients who are unable to comply with the treatment plan for CRC, at 6 weeks, 3 months and 6 months after diagnosis.
3. To identify barriers and solutions to CRC treatment compliance. Design: A mixed-methods study comprising quantitative pilot data from 3 tertiary cancer centres and qualitative work from interviews with patients and healthcare professionals.

Participants: Patients diagnosed with primary colorectal cancer.

Outcomes:

Primary outcome:

• Incidence of catastrophic expenditure due to out-of-pocket payments for cancer care at 3 timepoints: 6 weeks, 3 months and 6 months after CRC diagnosis.

Secondary outcomes:

• Compliance to the initial treatment plan at three timepoints: 6 weeks, 3 months and 6 months after CRC diagnosis.
• Patients and healthcare professionals perspectives on patient compliance to CRC treatment.
• Identify the 5 main drivers (items charged to the patient) of CRC treatment cost.
• Colorectal cancer stage at the time of diagnosis.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Aneel Bhangu, PhD; Phone Number: +44 (0) 121 3718121; Email: aneel.bhangu@gmail.com
• Study Contact Backup: Name: Joana Simoes, Master; Phone Number: +44 (0) 121 3718121; Email: simoes.jff@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made.

Description

Inclusion Criteria

• Adults aged 18+ years old. AND

• Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made:

  • In an multi-disciplinary team meeting (MDT);
  • OR in the outpatient clinic where an MDT is not available (surgery, oncology or radiotherapy outpatient clinic).

AND

• Undergoing treatment in the hospital where the MDT took place

Exclusion Criteria

• Patients with no histopathology available
• Telephone follow-up not possible

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catastrophic Expenditure at 6 months	Catastrophic expenditure (CE) will be defined as out of pocket payments for CRC treatment greater than 40% of patient income (assessed by an in-person questionnaire led by a researcher).	6 months after treatment decision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catastrophic Expenditure at 6 weeks	Catastrophic expenditure (CE) will be defined as out of pocket payments for CRC treatment greater than 40% of patient income (assessed by an in-person questionnaire led by a researcher).	6 weeks after treatment decision
Catastrophic Expenditure at 3 months	Catastrophic expenditure (CE) will be defined as out of pocket payments for CRC treatment greater than 40% of patient income (assessed by an in-person questionnaire led by a researcher).	3 months after treatment decision
Treatment compliance at 6 weeks	A compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.	6 weeks after treatment decision
Treatment compliance at 3 months	A compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.	3 months after treatment decision
Treatment compliance at 6 months	A compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.	6 months after treatment decision
Identification of the main drivers of treatment cost	5 most expensive items or services during colorectal cancer treatment	6 months after treatment decision
Colorectal cancer stage at the time of diagnosis	AJCC (American Joint Committee on Cancer) guidance - 8th edition	At the time of colorectal cancer diagnosis (coincident with timing of patient enrolment in the study)

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: NIHR Research Unit on Global Surgery

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CROC-20200503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No